CarboJet® CO2 Bone Lavage System

Basic Information

• Brand Name: CarboJet® CO2 Bone Lavage System
• Primary DI: 00898142001449
• Version / Model: 25-200-0280
• Catalog Number: 25-200-0280
• Company Name: Kinamed, Inc.
• Labeler DUNS: 184896645
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-05-17
• Public Version: 5
• Public Version Date: 2023-07-20
• Public Version Status: Update
• Public Device Record Key: 503a9f99-7cc5-4b71-9b48-746c6ef7abd5

Device Description

Disposable Femoral Nozzle

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FQH	LAVAGE, JET	General Hospital	880.5475	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65575	Bone cleaning gas-jet nozzle, single-use	A device designed to be attached to the distal end of a bone cleaning gas-jet handpiece to function as a nozzle that produces a jet of gas [usually carbon dioxide (CO2)] from its aperture to clean bone during an open surgical orthopaedic procedure. It is available in many designs, shapes and sizes and may be used with a Y-piece adaptor and suction pump to allow suction through its aperture. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00898142001449	GS1